Zoloft belongs to a class of prescription antidepressant medications called SSRIs, or selective serotonin reuptake inhibitors. The active ingredient in Zoloft is sertraline, and the drug functions by increasing the level of serotonin in the brain, thereby relieving depression and improving certain mood disorders. Zoloft garnered FDA approval in 1991 and has since been approved for the treatment of major depression, post-traumatic stress disorder, panic disorder, premenstrual dysphoric disorder, social anxiety disorder and obsessive-compulsive disorder. Zoloft is currently manufactured by pharmaceutical company, Pfizer Inc.
In recent years, a number of credible studies have surfaced in which researchers have sought to examine the adverse effects of fetal exposure to SSRI antidepressants like Zoloft. According to these studies, women who take SSRIs during pregnancy may significantly increase their risk of giving birth to infants with one or more major birth defects, including limb defects. Unfortunately, according to the Journal of the American Medical Association, more than 80,000 pregnant women are prescribed SSRI antidepressants like Zoloft in the United States in any given year.
Limb defects occur when an entire upper or lower limb, or portion of the limb, fails to form properly during fetal development. Limb defects can present as a complete absence of a limb, overgrowth (the limb is larger than normal), undergrowth (the limb is smaller than normal), duplication (extra fingers or toes), failure to separate (webbed fingers or toes), or constriction band syndrome (a constricting band of tissue forms around the limb, restricting blood flow and tissue growth). One of the most common types of limb defect is a malformation of the foot called club foot.
Club foot is a congenital birth defect in which one or both of a child’s feet fail to fully develop in utero, resulting in feet that are smaller than normal and internally rotated at the ankle. While this defect is virtually painless at birth, it can worsen over time and become an extremely debilitating condition later in life. Without treatment, the child may begin to walk on the outsides of his feet or ankles, causing large sores or callouses to form. An affected child may also suffer from restricted calf muscle growth and an awkward gait.
There are a number of treatment options available for children born with a limb defect, depending upon the type and severity of the malformation. Regardless of the specific aspects of the defect though, the major goal of limb defect treatment is to restore the limb to its normal function and appearance. In order to do so, the child may require any combination of treatments, including surgery, prosthetics, orthotics, or rehabilitation. In some cases, the defect may be impossible to fully correct, in which case the main goal of treatment would be to facilitate adaptation to the defect.
In 2006, the FDA issued a public health advisory warning patients and healthcare professionals about the increased risk of PPHN among infants exposed to SSRI antidepressants like Zoloft during pregnancy. The FDA also required all SSRI sponsors to change prescribing information to reflect the potential risk for PPHN. These FDA decisions were directly influenced by a New England Journal of Medicine study published that same year in which researchers found a six-times increased risk of PPHN among infants whose mothers took an SSRI like Zoloft after the twentieth week of pregnancy. According to the report, up to twelve out of 1,000 infants exposed to an SSRI in utero were born with PPHN, compared to the expected rate among the general population, which is one to two out of 1,000 infants.
In 2007, the NEJM published two additional studies, the first of which indicated that infants born to women who took an SSRI during the first trimester of pregnancy were nearly twice as likely to develop birth defects like club foot, limb defects and anal atresia. Researchers also found a potential link between these drugs and cleft lip, cleft palate and neural tube birth defects. According to the second study, infants whose mothers took an SSRI while pregnant were more than twice as likely to be born with devastating birth defects like anencephaly, omphalocele and craniosynostosis.
In 2010, the American Journal of Nursing published a study in which researchers identified SSRI exposure in utero as a risk factor for the development of serious heart defects among infants, particularly atrial septal defects and ventricular septal defects. According to the report, the prevalence of septal heart defects among exposed infants was 0.9%, compared to the rate among unexposed infants, which was 0.5%.
Zoloft has been classified by the FDA as a pregnancy category C medication, which means the drug has the potential to cause serious harm to a human fetus when taken during pregnancy. If you are currently pregnant or planning to become pregnant and you are taking Zoloft, consult your physician as soon as possible. It is never advised to discontinue use of a prescription medication without medical consent, as this may cause further harm to you or your child. However, with your doctor’s help, you may be able to find a safer way to treat your condition.
Seeking proper medical care for infants with a limb defect is likely to result in costly medical expenses. Unfortunately, this can be an overwhelming financial burden for many families, especially following a birth defect diagnosis. If you or a loved one has suffered from a limb defect and you believe Zoloft to be the cause, contact a Zoloft attorney as soon as possible. You may have grounds to file a Zoloft lawsuit against Pfizer in order to seek financial compensation for your injuries, medical expenses, and pain and suffering. Defective drug litigation can be a complicated process, but with the help of an experienced Zoloft attorney, victims of alleged Zoloft birth defects can feel confident that their case is being effectively and professionally represented.
The FDA measures the value of a medication by determining whether the possible benefits of the drug outweigh the potential risks involved. In order to make this decision, drug manufacturing companies must provide the FDA with accurate drug information, including any hazards associated with use of the drug. Unfortunately, some pharmaceutical companies intentionally withhold this information in order to ensure their drug is approved by the FDA and well-received by the public. This deceptive practice exposes millions of consumers to serious injury, illness and even death, without their knowledge. It is important for consumers to be aware of all the advantages and disadvantages of specific medications so that they can make an educated decision to continue or discontinue use of the drug. When drug companies conceal this information, consumers are the ones who suffer the consequences. Only by hiring a qualified Zoloft lawyer can victims of alleged Zoloft birth defects protect their rights and collect the compensation they deserve.